The use of toxoid for the prevention of tetanus neonatorum. Final report of a double-blind controlled field trial.
With a view to determining the effectiveness of a method for the control of tetanus neonatorum which would be independent of medical examination or care, a double-blind field trial covering 1618 women was conducted between 1961 and 1966 in a rural area of Colombia with an estimated existing tetanus neonatorum death rate of 11.6 per 100 births. The study group was given 1-3 injections of 1 ml of an aluminium-phosphate-adsorbed tetanus toxoid more than 6 weeks apart, and the control group a similar number of injections of an influenza-virus vaccine.There was no statistically significant difference between those in the two groups given one injection. Those in the control group given 2 or 3 injections had a tetanus neonatorum death rate of 7.8 deaths per 100 births, and the corresponding subjects in the study group had none. This difference is unlikely to have occurred by chance.
D000293:Adolescent; D000328:Adult; D002986:Clinical Trials as Topic; D003105:Colombia; D005260:Female; D006801:Humans; D007223:Infant; D007226:Infant Mortality; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000517:prevention & control*; D007273:Injections, Intramuscular; D008431:Maternal-Fetal Exchange; D008875:Middle Aged; D011247:Pregnancy; D013742:Tetanus / Q000517:prevention & control*; D013745:Tetanus Toxoid / Q000627:therapeutic use*
D013745:Tetanus Toxoid